Assets as used herein refers to physical things having parts that can be removed, repositioned, tampered with, displaced, connected to another part of the same asset, etc. (collectively referred to herein as a “change of state”). Detecting an asset's change of state is essential in today's market with wide application. For example, nearly all products ranging from bottled food products to high value electronics rely on tamper evident indicators to provide information on whether the product has been tampered with or otherwise altered. However, such visual cues can be easily missed or avoided. Taking the example of bottled food products, the cap may include a center portion that is popped upward to indicate that the bottle has been opened or otherwise tampered with after the food product was bottled by the manufacturer. Such a tamper indicator is often hard to detect as it requires close examination by the user as well as the user knowing what to look for with the tamper indicator. Similarly, the tamper indicating cap could have been removed altogether and replaced with a different cap that does not indicate tampering.
Similarly, many of today's tamper detection systems are easily replicated. For example, complex tamper indicating labels used by pharmaceutical companies to prevent drug counterfeiting and adulteration often include various hidden features such as Radio Frequency Identification (RFID) tags, holographic images, laser dots, color shifting ink, and self-tear features. The thinking is that it would be very complex for a counterfeiter to duplicate such complex tamper indicators. This may have been the case ten to twenty years ago, but it is now very easy for a counterfeiter to duplicate these types of indicators with the advent of technology by applying a new set of tamper indicating labels to an altered/tampered product.
In addition, all current tamper control systems rely on active inspection (i.e., requiring an individual to physically or visually examine the asset, scan an RFID tag on an asset, etc.) to determine if the product has been tampered with or not. This is very time consuming and heavily dependent on human inspector experience, knowledge, and vigilance.
Detecting an asset's change of state is also particularly helpful in monitoring use of an asset such as with systems for ensuring medication compliance. In ensuring optimal patient treatment, it is essential for patients to comply with a medication regiment prescribed by their health care provider (HCP). Similarly, because no two patients are identical, it is beneficial for HCPs to know whether the patient is in compliance with taking his/her prescribed medication to ensure the best care and medication prescribed for the patient. This information helps HCPs to determine if the medication is working for the patient or a better alternative medication regimen may benefit the patient more than the current regimen.
Similarly, knowing whether a patient has complied with a prescription regimen is necessary to determine the efficacy of new medications in clinical trials. In clinical trials, prefilled syringes are commonly used, and often a new drug will be introduced into the market in prefilled syringes first to be followed by more complex delivery devices such as autoinjectors, capsules, etc. Currently, there are no sensor or electronic systems embedded within prefilled syringes that can provide the HCPs with confirmation of syringe injection usage, which can then be used to correlate medication compliance with treatment efficacy. Today, the HCPs rely on the patients to report medication compliance and on their truthfulness outside of the clinical setting. This reliance on patient truthfulness in taking the prescribed medication regiment can be a significant risk in clinical trials, where the investigative new drug's efficacy, benefits and other results depend heavily on the patients' compliance with the prescribed medication regiment.
While some prior art systems utilize physical and electronics journals and reminder systems to assist and keep track of patient medication compliance, these systems are passive and depend on patient truthfulness and compliance. As such, they are believed to be only marginally effective. A HCP will not be able to tell if, for example, a patient simply filled in their journal right before going in to see their HCP to show compliance despite the patient having been non-compliant. Similarly, with the electronic reminders, the patient may simply indicate injection to silence the alarms without actually injecting the medication.
As such, there exists a need for a system to capture actual asset usage as it occurs and to transmit such information wirelessly (such as to ensure patient compliance and allow the HCPs to determine the efficacy of the medication in the syringe example problem described above).
What is needed therefor is a sensor having broad application to detect an asset's change in state and transmit such information wirelessly. Further, in order to have broad application, the sensor must be provided in a small, low-cost, and low-power package.